genotypic changes occurring in HIV-1 protease and reverse transcriptase regions after sequential STIs and their relation to clinical failure under the ART regimen at study entry

Enrollment:

20

Study Start Date:

September 2000

Study Completion Date:

July 2003

Primary Completion Date:

May 2003 (Final data collection date for primary outcome measure)

Detailed Description:

Our preliminary studies have shown that structured treatment interruption of highly active antiretroviral therapy (HAART) may boost patients' immune responses to HIV-1. In this study, we will test the hypothesis that repeated structured treatment interruptions will increase HIV-1 immunity and result in better control of viral replication than in controls. We will test this hypothesis by determining time to viral rebound after withdrawal of antiretroviral therapy in a randomized, non-blinded study of a well-characterized subject population from a single center. Patients in this study will be randomized to either treatment interruption or control groups. Patients will be monitored for adherence to therapy and changes in immune status following HAART interruption. CD4 percentage, CD 4 and CD8 mediated anti-HIV-1 responses, cell surface T-cell antigen expression, and thymic function will be assessed.

Agree to Medication Event Monitoring System monitoring of one component of antiretroviral regimen

HIV-1 viral load >10,000 copies/ml at any time prior to initiating the current uninterrupted HAART regimen

Willing to abstain from all immunomodulatory drugs during the study

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00051818